Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in Majorca, etc.). Aside from the beloved visage of our only child, we are most excited about seeing
Another One Bites the Dust: Plaintiff’s Causation Expert Excluded in Hernia Mesh Litigation
We spent Sunday evening in the familiar confines of a top-notch local professional theatre. The production was a short (80-minute), two-character play. It was entirely dialogue-driven, so everything the audience learned came out of a character’s mouth – there was no action to speak of. It was also perfectly cast, well-acted, and absorbing. By the
Plaintiffs’ Causation Expert Renounces His Own Conclusions – and Withdraws – in Mirena IIH Litigation
We have blogged before about the Mirena IUD litigation. Cases alleging injuries from device migration and uterine perforation were centralized in an MDL in the Southern District of New York, but, as we reported here, summary judgment was granted for the defendants in all of those cases when Daubert motions disposed of the plaintiffs’
Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices
Regular readers of this blog know that we have a pretty jaded view of many MDLs. Obviously consolidation makes sense, at least on paper, in terms of efficiency and the best use of scarce court resources. But, in practice, many MDLs promote a litigation “mob mentality,” in which the merits of individual cases are not important at the outset and, in the world of “settlement inventories” and “mass settlements,” may never draw the scrutiny of the judge or anyone else. Though we continue to hope that “Lone Pine” orders will burgeon and raise the standards for plaintiffs seeking to fly under the radar and await settlement, many MDLs remain “safe havens” for plaintiffs who can’t satisfy the burden of proving their claims.
And a recent decision from the hip implant MDL does nothing to disturb this reality. In that MDL, a longstanding “Explant Preservation Order” requires preservation of hip implant devices removed from plaintiffs during explant surgeries. The order requires plaintiffs to “make good faith efforts to ensure that [medical facilities] preserve” explanted devices and provides options for plaintiffs’ counsel to claim devices within 60 days of explant or, in the alternative, for the devices to be sent to the defendants. It requires all parties to handle explanted devices in accordance with a written protocol or consistent with “methods and practices accepted by those in the field of inspection and testing of orthopedic devices,” to notify each other of devices in their possession before the date of the order, and to make devices available to each other after inspection and testing. All of this, obviously, ensures that the critical evidence in this product liability MDL is preserved and handled in a fair and consistent manner.
In Marquis v. Biomet, Inc., et al., 2017 U.S. Dist. LEXIS 28465 (N.D. Ind. Mar. 1, 2017), the defendants moved for summary judgment against six plaintiffs. Five of these plaintiffs had had their devices explanted before they filed suit, or after they filed suit but before their cases were transferred into the MDL, and did not know what happened to their devices after they were explanted. The sixth plaintiff had several revision surgeries. During the first, the femoral head of her hip implant was replaced, and she asked for the explanted femoral head. She explained, “I figured I paid for it. I wanted it.” She kept the femoral head in her closet, didn’t disclose on her fact sheet that she had kept it, and didn’t tell anyone she had it until her deposition. The devices explanted during her subsequent surgeries were not preserved.Continue Reading Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices
Southern District of Indiana Excludes Plaintiffs’ Experts in Hernia Mesh Case
We loved La La Land. We were enchanted by the colors and the music and the dancing. We were transported by the dreams-come-true and saddened by the could-have-beens. We disappeared into the characters’ world for two hours and were not ready when the lights came up. For us, it was the epitome of a movie experience, and we were thrilled – momentarily – when it was announced as Best Picture. But, as all who witnessed Oscargate (and anyone who didn’t spend the last week in a submarine) can attest, simply saying it didn’t make it so.
Last week, in Bowersock, et al. v. Davol, Inc. and C.R. Bard, Inc., 2017 WL 711849 (S.D. Ind. Feb. 23, 2017) the United States District Court for the Southern District of Indiana reached the same conclusion, excluding the plaintiffs’ experts in a hernia mesh case. The plaintiffs claimed that a component of the defendants’ hernia mesh patch – a polyethylene terephthalate ring – perforated the intestines of the plaintiffs’ decedent, ultimately resulting in sepsis and death.
An autopsy was performed and concluded that the decedent’s small bowel and colon were intact, without perforation. But the hernia mesh patch was not retrieved from the decedent’s body before she was buried, so, seven years later (!!!), the plaintiffs had the body exhumed so the patch could be retrieved and analyzed, after which they submitted the reports of two causation experts – a surgeon and a biomedical engineer – to opine that components of the mesh patch caused the decedent’s injuries.
The Surgeon
The plaintiffs’ first expert, a general and gastrointestinal surgeon who used the defendants’ patch in his own practice, reviewed the patch explanted from the decedent’s exhumed body. He opined that the ring, though not broken, had buckled, creating a sharp edge that rubbed against the decedent’s bowel and perforated it.Continue Reading Southern District of Indiana Excludes Plaintiffs’ Experts in Hernia Mesh Case
Something We Can All Support: H.R. 985, Picking Up Where CAFA Left Off
Regular blog readers may recall that, every year, we eagerly await a Monday and Tuesday right around February 14th. This has nothing to do with Valentine’s Day (though we like a dozen roses and a box of chocolates as much as the next person.) No, at this time every year (for the past
Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation
For those of us who spend large chunks of our professional lives in mass tort MDLs, expressions like “settlement inventory” are ubiquitous. It is too easy to lose sight of the fact that these expressions put the rabbit in the hat, assuming that resourceful plaintiff lawyers will necessarily queue up for settlement payments at the end of the day and disregarding the fact that plaintiffs are supposed to be able to prove injury and causation before money changes hands. And so we were especially pleased to read last week’s decisions in the Lipitor MDL, in which the cautious and relentlessly thorough MDL judge granted defendant Pfizer’s omnibus summary judgment motion, dismissing all but a single newly-filed case, because the plaintiffs could not meet their burden of proving that Lipitor caused their diabetes. (There are two decisions relating to different dosages of Lipitor. You can read them here and here.)
The Lipitor MDL, created in February 2014, centralized cases in which female plaintiffs alleged that Lipitor – prescribed in dosages of 10 mg., 20 mg., 40 mg., and 80 mg. – caused them to develop Type 2 diabetes. In March and April of 2015, as trials of two bellwether cases approached, the plaintiffs served common expert disclosures of general causation experts, followed, in May and June, 2015, by specific causation expert disclosure in the two bellwether cases. After full expert discovery, Pfizer moved to exclude all of these experts. Ultimately, the court excluded the plaintiffs’ expert testimony on general causation with respect to Lipitor dosages of 10, 20, and 40 mg. The court also excluded the testimony of the bellwether plaintiffs’ specific causation experts, finding that the experts failed to rule out other possible causes of diabetes and relied impermissibly on temporal relationships, and granted summary judgment for Pfizer on the claims of both bellwether plaintiffs. (You can read our posts on these Daubert decisions here and here.)
However, the court left one general causation “window” open, based on one study finding that it was more likely than not that patients with certain characteristics who took 80 mg of Lipitor would not have developed diabetes in the absence of Lipitor. Thus, though neither of the bellwether plaintiffs had the requisite characteristics, it was possible that a plaintiff existed who took Lipitor at the 80 mg dosage and who could proffer a specific causation opinion that would survive Daubert.Continue Reading Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation
Court of Appeals Applies Law of Would-Be Filing Court in Fee Dispute in Hip Implant Case Filed Directly Into MDL
Last week, along with many of you, we attended the ACI Drug and Medical Device Conference in New York City. The quality of the presentations was uniformly high, and the collegiality and camaraderie were welcome, refreshing, and a lot of fun. There was plenty to drink. There was lots of food. Oh, and we got to see Hamilton! We should preface our comments by pointing out that we were skeptics – we knew how pricey (really, really pricey) tickets are, and we weren’t even positive we would enjoy this immensely innovative rap musical. To wit, one of our best beloved musicals of recent years was the wonderful, if short-lived, revival of Finian’s Rainbow that played the Great White Way a couple of years ago. We go for the traditional stuff, and had neither resources nor plans to spring for Hamilton.
But we got very lucky. A generous friend had bought four tickets a full year earlier in anticipation of the annual conference. And there was a last-minute cancellation. And we got to go. And it was worth all of the hype (and all of the money, if you have it). We enjoyed it so much that we came home and researched ticket availability to return with the Drug and Device Law Long-Suffering Companion. Tickets are on sale for next year, and we thought that we could avoid the crazy street prices by planning way ahead. Not so – even this far in advance, tickets (from official ticket sources, not ticket agencies) are way out of the reach of normal consumers. Sometimes, the early bird does not get the worm (or the greatest financial benefit).
And, with just a bit of creativity, we can glean the same message (among others) from today’s case. Dobbs v. DePuy Orthopedics, — F.3d —, 2016 WL 7015648 (Seventh Cir. Dec. 1, 2016), is an appeal of an attorney’s fee decision from the United States District Court for the Northern District of Illinois. (We’ll explain how it got there in a minute.) The plaintiff/appellant had direct-filed a product liability claim in the Hip Implant MDL in the Northern District of Ohio. Believing that the promised compensation was too low, he opted out of the global settlement and fired his lawyers, who had advised him to accept the global settlement, which included a 35% attorneys’ fee. (The global settlement provided one level of payment for unrepresented plaintiffs, and a second level, 35% higher, for represented plaintiffs.)
Less than two months after his lawyers withdrew their appearance, the plaintiff accepted the global settlement. Because he was considered “represented” for purposes of the settlement, he was paid the larger amount. (Not clear why he was considered “represented” when his lawyers had been fired.) His former lawyers asserted a lien on the award and sought to recover attorney’s fees. The MDL judge tried unsuccessfully to mediate the fee dispute in the Northern District of Ohio then transferred the case to the Northern District of Illinois, where the case would have been filed if the MDL had not been pending.Continue Reading Court of Appeals Applies Law of Would-Be Filing Court in Fee Dispute in Hip Implant Case Filed Directly Into MDL
Expert Testimony in Sheep’s Clothing is Still Expert Testimony, Says Georgia Supreme Court
Sometimes it takes a lot of words to say something. The Iliad. War and Peace. SCOTUS’s Obergfell decision. But sometimes, in just a few words, it is possible to create an image, or stir a memory, or underscore a point. Call me Ishmael. I have a dream. A rose by any other name would smell as sweet. And, apropos of sweet-smelling roses, today’s very short Georgia Supreme Court decision makes the point that expert opinions are expert opinions even when clothed as fact testimony, and must be excluded from evidence unless they meet the relevant admissibility standards. Yugueros v. Robles, 2016 WL 6407314 (Ga. Oct. 31, 2016), is not a drug or device decision. It is a medical malpractice case, but its holding is relevant for anyone who deals with opposing experts. Which we do, regularly and painfully. (You can see a recent post on a similar issue here.)
In Yugueros, the appellant performed extensive cosmetic surgery on the appellee’s decedent (his wife). Subsequently, Mrs. Robles went to the emergency room suffering from severe abdominal pain. After an abdominal x-ray, which the E.R. doctor determined to be “unremarkable,” Mrs. Robles was discharged. A radiologist who later saw the abdominal film could not rule out the presence of free air in the abdomen, which “could be a normal post-operative condition or could indicate a more serious issue.” Yugueros, 2016 WL 6407314 at *1. The radiologist recommended a CT scan and posted his opinion in Mrs. Robles’s electronic medical record.Continue Reading Expert Testimony in Sheep’s Clothing is Still Expert Testimony, Says Georgia Supreme Court
Expert Who Admitted That He Was Unqualified and That His Opinions Lacked Methodology Not Allowed to Testify in Zoloft Litigation.
Last week, the Drug and Device Law Lifelong BFF asked us if we were interested in a quick trip to New York to use tickets for an early morning taping of “Live with Kelly.” Sure, we said – sounds like fun. And so, after nearly two hours in line and significant drama over whether we were in front of or behind the “make it into the studio” line we were told would be drawn, we were seated. And we had a great time. Kelly is as adorable and effervescent as she appears on television. Her guest co-host interjected continuous comments from the “intelligent and engaged host” playbook. And the guests were bona fide celebrities whom it was fun to observe at a distance of a scant ten feet. But what was most impressive about the whole exercise was the opportunity to see what goes into the daily illusion that the hosts and the guests are responsible for the “workings” of an interview show. Because, in fact, the stage was swarming with people who kept the machine operating, and the familiar faces were a tiny nucleus at the center of it all. There were stylists and producers and directors and cameramen everywhere – so much so that they often blocked our view and we resorted to watching on monitors or on the screens mounted on the huge cameras. And we realized that there would be no final product without every piece of this puzzle.
In today’s case, the absence of a requisite puzzle piece – a qualified specific causation expert – doomed the plaintiff’s case. In In re Zoloft Litigation, 2016 WL 5958372 (W. Va. Cir. Ct. Oct. 5, 2016), the court considered the defendants’ motion to exclude the plaintiff’s (general and specific) causation expert, who was a research scientist and not a medical doctor.. The expert had designated the expert to render the opinions that the defendants’ product could cause “deleterious effects both in developmental autonomy, neuroautonomy, and neurological function including the development of autism and other neurodevelopmental disorders,” 2016 WL 5958372 at *1 (emphasis in original), and that the plaintiff’s mother’s ingestion of the product while she was pregnant caused a seizure disorder and “cognitive and neurobehavioral disorder” in the plaintiff. Id.
The expert was deposed, on successive days, in four pending cases including this one. After the first day of his deposition, when he testified on behalf of two other plaintiffs, he met with plaintiffs’ counsel for several hours and drafted an updated disclosure in this case, omitting all references to autism and deleting the opinion that the defendants’ product caused the plaintiff’s seizures. Instead, the new disclosure stated that the expert would testify that the plaintiff’s mother’s use of the product during pregnancy was a cause of the plaintiff’s developmental delays. Id. at *2. Asked to explain why he revised his disclosure, the expert testified that, after “going back over the [plaintiff’s] records in preparation for” his deposition, he “felt it was prudent to focus on the developmental delay” and to delete the opinions that the defendants’ product caused autism and epilepsy. Id. Why? Because the plaintiff had not been clinically diagnosed with autism, and because there was not a “good differential diagnosis” concluding that the plaintiff’s seizures “occurred at the right time to be related to his mother’s use” of the defendants’ product.” Id.Continue Reading Expert Who Admitted That He Was Unqualified and That His Opinions Lacked Methodology Not Allowed to Testify in Zoloft Litigation.